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Multiplex gene-panel testing for lung cancer patients
Yasushi Yatabe1, Kuniko Sunami2, Koichi Goto3
1Department of Diagnostic Pathology, National Cancer Center, Tokyo, Japan.
Abstract:
The year 2019 was considered to be the first year of cancer genome medicine in Japan, with three gene-panel tests using next-generation sequencing (NGS) techniques being introduced into clinical practice. Among the three tests, the Oncomine CDx Target test was approved under the category of regular molecular testing for lung cancer, which meant that this test could be used to select patients for molecularly targeted drugs. Conversely, the other two tests, NCC OncoPanel and FoundationOne CDx, were assigned to be used under the National Cancer Genome Medicine Network, and implementation was restricted to patients for whom standard treatment was completed or expected to be completed. These NGS tests can detect a series of genetic alterations in individual tumors, which further promotes the development of therapeutic agents and elucidates molecular pathways. The NGS tests require appropriate tissue size and tumor cell content, which can be accessed only by pathologists. In this report, we review the current reimbursement schema in our national healthcare policy and the requirements of the specimens for NGS testing based on the recently published 'Guidance of Gene-panel Testing Using Next-Generation Sequencers for Lung Cancer', by the Japanese Society of Lung Cancer.
Insights
Japan
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- 2019 marked the introduction of cancer genome medicine in Japan with three next-generation sequencing (NGS) gene-panel tests.
- These tests detect genetic alterations in tumors, aiding therapeutic development and understanding molecular pathways.
- Pathologists play a crucial role in ensuring adequate tissue size and tumor cell content for NGS testing.
Purpose of the Study:
- To review Japan's current reimbursement policies for NGS cancer gene-panel testing.
- To outline specimen requirements for NGS testing based on recent Japanese Society of Lung Cancer guidelines.
Main Methods:
- Review of national healthcare reimbursement policies for molecular testing.
- Analysis of the 'Guidance of Gene-panel Testing Using Next-Generation Sequencers for Lung Cancer' by the Japanese Society of Lung Cancer.
- Comparison of the clinical application and accessibility of different NGS tests (Oncomine CDx Target, NCC OncoPanel, FoundationOne CDx).
Main Results:
- One NGS test (Oncomine CDx Target) is approved for regular molecular testing in lung cancer for targeted therapy selection.
- Two other NGS tests (NCC OncoPanel, FoundationOne CDx) are restricted to patients who have completed or will complete standard treatment.
- These tests are implemented within the National Cancer Genome Medicine Network.
Conclusions:
- The accessibility and application of NGS gene-panel tests in Japan differ based on their approval status and reimbursement.
- Understanding specimen requirements and national guidelines is essential for effective implementation of NGS in lung cancer diagnostics.
- Pathologist involvement is critical for successful NGS testing in clinical practice.
